Welcome

Welcome to the POZ/AIDSmeds Community Forums, a round-the-clock discussion area for people with HIV/AIDS, their friends/family/caregivers, and
others concerned about HIV/AIDS. Click on the links below to browse our various forums; scroll down for a glance at the most recent posts; or join in the
conversation yourself by registering on the left side of this page.

Privacy Warning: Please realize that these forums are open to all, and are fully searchable via Google and other search engines. If you are HIV positive
and disclose this in our forums, then it is almost the same thing as telling the whole world (or at least the World Wide Web). If this concerns you, then do not use a
username or avatar that are self-identifying in any way. We do not allow the deletion of anything you post in these forums, so think before you post.

The information shared in these forums, by moderators and members, is designed to complement, not replace, the relationship between an individual and his/her own
physician.

All members of these forums are, by default, not considered to be licensed medical providers. If otherwise, users must clearly define themselves as such.

Forums members must behave at all times with respect and honesty. Posting guidelines, including time-out and banning policies, have been established by the moderators
of these forums. Click here for “Am I Infected?” posting guidelines. Click here for posting guidelines pertaining to all other POZ/AIDSmeds community forums.

We ask all forums members to provide references for health/medical/scientific information they provide, when it is not a personal experience being discussed. Please
provide hyperlinks with full URLs or full citations of published works not available via the Internet. Additionally, all forums members must post information which are
true and correct to their knowledge.

PrintShareMarch 21, 2012Six research teams have begun using the first phase of the Blue Waters sustained-petascale supercomputer to study some of the most challenging problems in science and engineering, from supernovae to climate change to the molecular mechanism of HIV infection.

Blue Waters Early Science SystemThe Blue Waters Early Science System, which is made up of 48 Cray XE6 cabinets, represents about 15 percent of the total Blue Waters computational system and is currently the most powerful computing resource available through the National Science Foundation.

"This is an exciting and important milestone in the Blue Waters project," said Irene Qualters, program director of the NSF Office of Cyberinfrastructure. "It began as an idea, and now thanks to sustained collaborative efforts by the entire project team, the vendor and the science teams, this computational tool is beginning to advance fundamental understanding in a wide range of scientific topics."More than two dozen research teams have been awarded Petascale Computing Resource Allocations (PRAC) through a competitive NSF-led process. The PRAC awards enable these teams to work with NCSA to prepare their codes to take full advantage of Blue Waters and other extreme-scale computing systems. The teams submitted proposals outlining how they could use the Early Science System during the limited time it is available before being integrated into the full Blue Waters system; it was challenging to select just a few of the teams to achieve the first Blue Waters science results.

"All of these outstanding science and engineering teams are poised to do great, boundary-expanding work. The achievements of the first set of pioneers will soon be followed by those of their colleagues when the full system becomes available later this year," said NCSA Director Thom Dunning, principal investigator for the Blue Waters project.

The Early Science System research teams and their projects are:

Homayoun Karimabadi's team, University of California-San Diego, is modeling high-temperature plasmas, including magnetic reconnection and flux transfer events to better understand the impact of the solar wind and solar flares on the Earth's atmosphere.

The first all-atom structure of an HIV virus capsid in its tubular form, courtesy of the Theoretical and Computational Biophysics research group led by Klaus Schulten.Brian O'Shea and his team, Michigan State University, are simulating the formation and evolution of the Milky Way's most distant ancestors, a population of small galaxies formed shortly after the Big Bang. These simulations will be more accurate and full featured than any performed before. Previous simulations have modeled volumes of 1 megaparsec; the highest resolution subvolume of O'Shea's simulation will be more than 200 times this size.

Klaus Schulten and his team at the University of Illinois at Urbana-Champaign are studying the protein capsid that encases the HIV-1 genome. The process through which this capsid disassembles, releasing its genetic material, is a critical step in HIV infection. Schulten's group will simulate a cylindrical capsid consisting of 12.5 million atoms.

Robert Sugar's team, University of California, Santa Barbara, is conducting lattice quantum chromodynamics studies, which deal with sub-atomic physics. The first goal is to examine the charmonium spectrum (the bound state of charms and anti-charms); this requires challenging simulations with very small lattice spacing and very large lattice dimensions. The team's second effort deals with exotic mesons, which are prime territory in which to hunt for gluons. Sugar's team aims to use the Blue Waters Early Science System to confirm or refute that this state exists and can be identified experimentally.

Stanford Woosley's team, University of California Observatories, is researching explosive burning in Type Ia supernovae, which are used as "standard candles" for surveying astronomically vast distances. Using the Early Science System, Woosley's team will be able to achieve unprecedented resolution at the finest level of their adaptive mesh refinement simulations.

Donald Wuebbles and his team will simulate the end of both the 20th and 21st centuries at 0.25° global resolution. These high-resolution time slices will enable his team to explore changes in the frequency and intensity of extreme events, such as tropical cyclones and mid-continental thunderstorms, that are not adequately resolved in global climate models at lower resolution. By using the Early Science System, Wuebbles' team hopes to contribute high-resolution results in time for the next assessment report of the Intergovernmental Panel on Climate Change.For more information about Blue Waters and the science and engineering research it will support, see http://www.ncsa.illinois.edu/BlueWaters.____________________

A group of scientists recently discovered a major vulnerability of HIV strains: the antibody PGT 128.

HIV (Human Immunodeficiency Virus) is a virus that prevents the immune system from working properly. This condition cripples the body from defending against infections that are life-threatening.

For decades, scientists have been improving vaccines that allow people with HIV to live longer. But no vaccine could prevent all HIV infections because HIV mutates quickly. The recent discovery of the antibody PGT 128 is groundbreaking due to its unprecedented effectiveness on a broad range of HIV strains.

An antibody PGT 128 attaches to an HIV strain and penetrates its glycan shield. Glycan shields are what normally protect the strain from the body’s immune system, but the antibody PGT 128 binds to the strains and reaches through the glycan shield. Finally, it neutralizes the strain by passing through the shield and grabbing the protein called GP120.

Scientists predict that PGT 128 is effective against HIV strains precisely because most of them have glycan shields. How broad are its effects? Researchers from the United States, United Kingdom, Japan and the Netherlands tested blood of HIV-positive volunteers and concluded that PGT 128 is effective against 70% of HIV strains.

Although the antibody does not provide a solution to all HIV infected people around the world, scientists are optimistic about finding a potential lifetime cure because of the success of this research. "We'll probably need multiple targets on the virus for a successful vaccine, but certainly PGT 128 shows us a very good target," said Dennis Burton, a Professor at The Scripps Research Institute and scientific director of the International AIDS Vaccine Initiative’s (IAVI) Neutralizing Antibody Center, in a press release.

Perhaps the most exciting fact is not that PGT 128 can neutralize about 70 percent of the world’s HIV strains. It’s the finding that most HIV strains, despite their unpredictable mutations, share common structures that can make them vulnerable to certain antibodies, providing hope that we can fight the virus more effectively.

FDA Approves INTELENCE® (etravirine) Tablets for Treatment-Experienced Pediatric Patients with HIV-1, Following Priority ReviewTitusville, NJ (March 27, 2012) – Janssen Therapeutics, Division of Janssen Products, LP, announced today the U.S. Food and Drug Administration (FDA) has approved INTELENCE® (etravirine) to be administered in combination with other antiretroviral (ARV) medications for treatment of human immunodeficiency virus 1 (HIV-1) in treatment-experienced pediatric patients (6 years to <18 years old) who are experiencing virologic failure with HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other ARVs.

This approval, which follows FDA priority review of the company’s supplemental New Drug Application, expands the INTELENCE indication and makes it the only NNRTI indicated for this use in both treatment-experienced children and adults with resistance to an NNRTI and other ARVs. The approval includes a new 25mg dose to allow for weight-based dosing in pediatric patients (6 years to <18 years old and weighing at least 16kg or 35.2 lbs). The 25mg tablet is expected to be available in the first half of May.

“This indication fulfills an important need in the U.S. among treatment-experienced young children and adolescents living with HIV,” said David Anderson, M.D., Medical Director at Janssen Therapeutics. “This approval also expands the treatment options INTELENCE offers, and reinforces our company’s commitment to serving the diverse needs of the HIV treatment community.”

INTELENCE should be taken orally following a meal. For patients unable to swallow INTELENCE tablets whole, the tablets may be dispersed in a glass of water. Once the tablets are dispersed in water, they can be added to other liquids such as milk or orange juice. The use of grapefruit juice, warm liquids or carbonated beverages should be avoided.

The approval is based on 24-week data from the PIANO (Pediatric trial with INTELENCE as an Active NNRTI Option) study, which evaluated the pharmacokinetics, safety, tolerability and efficacy of INTELENCE in combination with other ARVs in antiretroviral treatment-experienced pediatric patients 6 years to <18 years of age.

About INTELENCEIn January 2008, the FDA granted accelerated approval to INTELENCE for use in combination with other ARVs for the treatment of HIV-1 infection in treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to an NNRTI and other antiretroviral agents. In November 2009, INTELENCE received traditional FDA approval based on 48-week data from the DUET 1 and DUET 2 studies.

In treatment-experienced adult and pediatric patients, the following points should be considered when initiating therapy with INTELENCE:Treatment history and resistance testing should guide the use of INTELENCE due to concerns for potential cross-resistance.In patients who have experienced virologic failure on an NNRTI-containing regimen, do not use INTELENCE in combination with only N[t]RTIs.The use of other active antiretroviral agents with INTELENCE is associated with an increased likelihood of treatment response.The safety and efficacy of INTELENCE have not been established in pediatric patients less than 6 years of age or in treatment-naïve adult or pediatric patients.INTELENCE does not cure HIV-1 infection or AIDS. You must stay on continuous HIV therapy to control HIV infection and decrease HIV-related illnesses.

About the PIANO Study The 24-week data from the PIANO (Pediatric Trial with INTELENCE as an Active NNRTI Option) study was presented at the 2011 International AIDS Conference in Rome. The data were from a single-arm, Phase 2 trial evaluating the pharmacokinetics, safety, tolerability, and efficacy of INTELENCE in 101 antiretroviral treatment-experienced HIV-1 infected pediatric subjects 6 years to <18 years of age and weighing at least 35.2 lbs.

The frequency, type and severity of adverse drug reactions in pediatric subjects were comparable to those observed in adults, except for rash which was observed more frequently than in adults. Rash (≥ grade 2) occurred in 15% of pediatric subjects. Most often, rash was mild to moderate, of macular/papular type, and occurred in the second week of therapy. Rash was mostly self-limiting and generally resolved within 1 week on continued therapy. The discontinuation rate for rash was 4%. Rash occurred more commonly in females than males.

About INTELENCE INTELENCE is a prescription HIV medicine that is used with other HIV medicines to treat HIV (human immunodeficiency virus) infection in adults and children 6 years of age and older. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). INTELENCE is a type of HIV medicine called a non-nucleoside reverse transcriptase inhibitor (NNRTI), also known as a non-nuke.

INTELENCE must be taken in combination with other HIV medicines. INTELENCE is used in people who are already taking or have taken NNRTI and other HIV medicines and these medicines are not controlling their HIV infection.

The use of other medicines active against your HIV in combination with INTELENCE may increase the likelihood of your overall treatment response. If a non-nuke regimen has stopped working for you, INTELENCE should not be taken with only nucleoside/nucleotide reverse transcriptase inhibitors, also known as nukes. Your healthcare professional will work with you to find the right combination of other HIV medicines.

It is important that you remain under the care of your healthcare professional during treatment with INTELENCE.

It is not known if INTELENCE is safe and effective in children less than 6 years of age.

INTELENCE does not cure HIV infection or AIDS. You must stay on continuous HIV therapy to control your HIV infection and decrease HIV-related illnesses.

Ask your healthcare professional if INTELENCE is right for you.

Important Safety Information

What are the possible side effects of INTELENCE?

INTELENCE can cause serious side effects including:Severe skin rash and allergic reactions. Skin rash in general is a common side effect of INTELENCE, and was seen more commonly in children than adults in clinical studies. Rash can be serious and may potentially lead to death. If you get a rash with any of the following symptoms, stop taking INTELENCE and call your healthcare professional right away: hives or sores in your mouth, or your skin blisters and peels, trouble swallowing or breathing, swelling of your face, eyes, lips, tongue, or throat, fever, yellowing of the skin or whites of the eyes, dark urine, or pain on the right of the stomach-area (abdominal pain).

Changes in body shape or body fat. The cause and long-term health effects of these conditions are not known at this time.

Changes in your immune system can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden. In adults, common side effects of INTELENCE include tingling, numbness, or pain in hands or feet.

In children, diarrhea is a common side effect of INTELENCE. This is not a complete list of all side effects. If you experience these or other symptoms, contact your healthcare professional right away.

What should I tell my doctor before I take INTELENCE?Before taking INTELENCE, tell your healthcare professional if you have liver problems, including hepatitis B or C have any other medical conditions, or if you are pregnant, planning to become pregnant, or breastfeeding.

It is not known if INTELENCE can cause harm to your unborn baby. Do not breastfeed if you are taking INTELENCE. You should not breastfeed if you have HIV because of the risk of passing HIV to your baby.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Taking INTELENCE with certain medicines may cause serious side effects or may result in loss of its effectiveness (which could increase your risk for developing resistance to INTELENCE or other HIV medicines that are like it).

THURSDAY, March 29 (HealthDay News) -- A stronger immune response occurs in women who have been infected with two different strains of HIV by two different sexual partners than in women infected with one strain of HIV, a new study finds.

This type of dual infection is called HIV "superinfection."

The finding that a mixture of different HIV strains may be one way to trigger a more powerful immune system antibody response may prove useful in efforts to develop an HIV vaccine in the fight against AIDS, according to the researchers at the Fred Hutchinson Cancer Research Center in Seattle.

The researchers tracked the immune activity of 12 superinfected women in Kenya for five years. Compared to singly infected women, the superinfected women had about 70 percent more neutralizing antibodies (agents the immune system uses to fight invaders) and their antibodies' ability to neutralize HIV was almost 50 percent stronger.

The study appears online March 29 in the journal PLoS Pathogens.

"We found that women who had been infected twice not only had more potent antibody responses, but some of these women had 'elite' antibody activity, meaning that they had a broad and potent ability to neutralize a wide variety of strains of HIV over a sustained period of time," senior author Julie Overbaugh said in a research center news release.

Only about 1 percent of HIV-infected people are "elite neutralizers," the authors noted.

"Individuals who become superinfected with a second virus from a different partner represent a unique opportunity for studying the antibody response and may provide insights into the process of developing broad neutralizing antibodies that could inform HIV-vaccine design," Overbaugh said.

It is estimated that more than 1.1 million Americans have HIV and someone becomes newly infected about every 10 minutes, according to the U.S. Department of Health and Human Services.

Many experts consider an HIV vaccine to be the best way to offer long-term protection against HIV but efforts to develop such a vaccine have achieved only limited success.

Posted on March 26, 2012 by adminResults from a small study of 100 co-infected people treated with Victrelis + pegylated interferon + ribavirin showed that 61% had undetectable viral loads at 12 weeks after stopping their hepatitis C treatment.

All study participants were given pegylated interferon + ribavirin for the first 4 weeks of treatment. About 2/3 had Victrelis added to their regimen for the next 44 weeks while the other third continued on pegylated interferon + ribavirin alone. Nearly all participants were on a boosted protease inhibitor HIV regimen.

The average age of the participants was 44, and 31% were women. Most people had high HCV viral loads, while 5% had cirrhosis. Nearly 65% had HCV genotype 1a while the others had 1b. CD4 counts averaged 580 and all had undetectable HIV viral load.

Two people saw their HCV return after being undetectable at week 48.HIV viral loads became detectable in 3 people taking Victrelis.CD4 counts tended to decrease in everyone; however, the CD4% did not change.High rates of side effects were seen in the Victrelis group, including bad taste (28%), vomiting (28%), diarrhea (28%), anemia (41%), fever (36%), headache (23%), appetite loss (34%) and fatigue (36%). Serious anemia occurred in 5% and low neutrophil counts (27%).A larger study will start enrolling by the end of the year.

A review of several recent clinical advances indicates that researchers are making progress in finding methods to activate latent HIV. Results also confirm that activating dormant HIV to render it susceptible to antiretrovirals may represent a viable strategy to reduce latent infection.“Some interventions that have already been tested have been relatively well tolerated,” said Dr. Sharon Lewin, director of the Infectious Disease Unit at Alfred Hospital in Melbourne, Australia, and author of the review.Dr. Lewin noted that results so far are promising but still preliminary.“Perhaps some very early signals that [Zolinza] and disulfiram might increase HIV production in vivo,” said Dr. Lewin.“How that’s happening we still need to address, and we have no evidence that it’s made any difference to the number of latently infected cells,” she added.The results were presented earlier this month at the 19th Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle.Latent infection refers to HIV that is not actively replicating. In such cases, the virus inserts its own genetic material into a person’s DNA and remains dormant for an extended period of time.Since most antiretroviral drugs target actively replicating HIV, they fail to eliminate latent forms of the virus. If antiretroviral therapy is stopped, latent HIV returns to an active form and reproduces quickly, resulting in a rebound of viral load (amount of virus in the blood).As a result, many researchers believe that activating latent HIV is a necessary step for curing people of the infection. Strategies to target latent HIV often involve a combination of virus-activating treatment with standard antiretroviral therapy (see related AIDS Beacon news).In her review at CROI, Dr. Lewin summarized results from several clinical trials that are using different approaches to activate latent HIV.Histone Deactylase InhibitorsHistone deacetylase (HDAC) inhibitors are a class of drugs that are currently in clinical trials to test their ability to activate latent HIV. According to Dr. Lewin, results so far have been suggestive but somewhat contradictory.The U.S. Food and Drug Administration (FDA) approved one HDAC inhibitor, Zolinza (vorinostat), in 2006 for the treatment of a type of lymphoma. According to Dr. Lewin, Zolinza is currently being tested both by her own group in Melbourne, Australia, and by Dr. David Margolis’ group at the University of North Carolina (UNC) in Chapel Hill.In the Melbourne-based study, nine HIV positive individuals (with HIV infection that was well controlled on antiretroviral therapy) received 400 mg of Zolinza daily for two weeks. Blood and samples of tissue from the participants’ rectums were collected before and after Zolinza treatment to measure the activity of HIV genetic material, a measure of activated latent HIV, in host CD4 (white blood) cells.According to Dr. Lewin, results from the study showed that multi-dose treatment with Zolinza did not lead to a significant increase in the activation of latent HIV as expected, even when participants were followed up for 12 weeks. She reported that treatment-associated side effects such as lethargy, diarrhea, and nausea were seen in 90 percent of participants.The study by researchers at UNC-Chapel Hill included six HIV-positive individuals whose HIV infection was well controlled with antiretroviral therapy. In this study, participants received a single 400 mg dose of Zolinza.In contrast to the Melbourne-based trial, the results from this study suggested that Zolinza treatment resulted in a five-fold increase in the activity of HIV genetic material without serious side effects (see related AIDS Beacon news).Other HDAC inhibitors such as panobinostat, gavinostat, and belinostat are also currently in clinical development. Preclinical results suggest that they effectively activate latent HIV in the laboratory; however, their ability to activate latent HIV in people has not yet been tested.Other StrategiesDr. Lewin also reported on clinical trial results for two other HIV-activating drugs: disulfiram and anti-PD1 antibodies.Disulfiram (Antabuse) is an FDA-approved drug to help treat alcoholism. In 2011, researchers at Johns Hopkins University discovered that disulfiram can activate latent HIV. How disulfiram activates latent HIV is not well understood and remains under investigation.Dr. Lewin discussed results from a recent disulfiram-based clinical trial by Dr. Steven Deeks’ group at the University of California at San Francisco and Dr. Adriana Andrade’s group at Johns Hopkins University. Fourteen HIV-positive individuals whose HIV was well controlled with antiretroviral therapy received 500 mg of disulfiram daily for two weeks.Results from the trial indicated no significant differences in plasma viral load after disulfiram treatment, suggesting that the disulfiram did not significantly activate latent HIV (see related AIDS Beacon news). However, since a subset of participants showed a significant increase in viral load as early as two hours after disulfiram treatment, the researchers plan to study the drug’s efficacy at shorter time periods.Another approach that is being investigated to activate latent HIV is the use of anti-PD1 antibodies.Anti-PD1 antibodies bind to a molecule called ‘programmed cell death 1’ (PD1) on the surface of white blood cells. Upon chronic exposure to HIV, some white blood cells become ‘exhausted’, meaning that they lose function and cannot be activated anymore. Exhausted white blood cells produce high levels of molecules on their surface, including PD1, that prevent the cells from being activated further.Previous studies have shown that in people with HIV, exhausted cells that produce high levels of PD1 harbor more latent HIV than active cells.Dr. Nicolas Chomont’s group at the Vaccine and Gene Therapy Institute in Florida investigated whether antibodies that bind to PD1 on the surface of exhausted cells can mask it and help reactivate exhausted white blood cells. Reactivating the cells may help reduce latent HIV.Results from the study indicate that treating white blood cells obtained from HIV-positive individuals with anti-PD1 antibodies in the laboratory led to increased activity of the integrated HIV genetic material, suggesting that latent HIV was being activated.According to Dr. Lewin, Merck and Bristol Myers-Squibb both currently have anti-PD1 antibodies in clinical trials, for diseases such as melanoma. She also indicated that plans for a trial in people with HIV are underway.Challenges And Future DirectionsIn evaluating the efficacy of latent HIV activators, Dr. Lewin underscored the need for a better understanding of what parameters to measure and at what time points.“There’s still lots that we don’t know,” said Dr. Lewin. She noted that, of the drugs that are possible HIV activators, researchers still need to find the best dosages and figure out when to test for activated HIV. Scientists also are still working on how best to determine whether the drugs are effective and how to measure latent HIV.Dr. Lewin also suggested that eradicating HIV will likely take a combination of multiple strategies. She noted that the simultaneous use of two approaches to activate latent HIV sometimes produces significantly better results than using the agents individually, and that activation of latent HIV will almost certainly need to be combined with other approaches, such as intensification of treatment with antiretrovirals.For more information, please see the webcast on the CROI 2012 website.Photo by Crafty_Dame on Flickr – some rights reserved.

What a year it has been with regard to scientific research, new treatment, new guidelines, and the hiring of D.R Colfax to run the Office of AIDS Policy (ONAP) - all game changing events in the face of HIV/AIDS.

HPTN052 – Treatment as Prevention One of the biggest highlights of the past year in May 2011 was the revelation of a study known as HPTN052 conducted by Professor Myron Cohen of the University of North Carolina at Chapel Hill. The study revealed that those on Anti-Retroviral therapy are 96% less likely to transmit the virus to their partner. This stresses the importance starting Anti-Retroviral early to suppress viral load, and lessen the likelihood of transmitting the virus. Thus, Treatment as Prevention was coined.

Complera – Once a day

Then, in August 2011 the FDA approves Complera. A once daily pill which consists of Gilead’s Truvada (emtricitabine/tenofovir) and Tibotec Pharmaceuticals’ Edurant (rilpivirine), which was approved by the FDA in May. The only other once daily pill on the market is Atripla that has been out since 2007.

CROI 2012 – Many research developments

Jumping ahead to March 2012 at the Conference of Retroviruses and Opportunistic Infections (CROI) promising research was announced. Currently 31 drugs are approved to treat HIV, and a list of these drugs can be found at www.positivelyaware.com/chart , but in the coming year this chart will be expanded. One drug, dolutegravir (still experimental) is a second-generation integrase inhibitor that is active against HIV strains resistant to first generation inhibitors. This drug combined with other drugs in a once a day pill is currently being explored.

The other promising drug is GILEAD’s ‘QUAD’ tablet containing the experimental integrase inhibitor elvitegravir and boosting agent cobicistat along with tenofovir and emtricitabine and tenofovir. This quad tablet has been submitted for FD A approval – and seems to address the limitations of sustiva’s psychological side effects, such as found in Atripla.

Also from CROI 2011; Latent HIV was discussed. This is HIV that is not actively replicating and it lies dormant in reservoirs (In the gut, the brain…etc.) throughout the body. This has been the biggest challenge, how to eliminate latent HIV from these reservoirs? Anti-retrovirals work on blocking replication of HIV, but do not work on latent HIV.

Eradicating latent HIV is a TOP priority for scientists attempting to cure HIV and currently several drugs are currently being tested for their ability to reduce or eliminate this hidden reserve of the virus. One of the most discussed avenues behind curing AIDS is intensifying ARV treatment and combining new potent and less toxic drugs that can reach HIV infected latent cells, activate them and with those same drugs inhibit their ability to replicate – then it may be possible to eradicate HIV from the body. Also, results of a small study using Zolina, a drug used to treat lymphoma may successfully reduce the size of the latent HIV reservoirs in HIV positive adults taking antiretrovirals. This study indicates latency can be targeted and will continue to be a significant step towards eradication of HIV.

Also at CROI 2012 Researchers in many of their discussions noted that rates of Metabolic problems, notably cardiovascular disease and diabetes, are elevated in people living with HIV.

CROI 2012: Co-Infection; new hope

With regard to co-infection of HIV and Hepatitis C Merck’s new drug boceprevir had a cure rate of 60 percent in people who completed 48 weeks of treatment and who had a sustained virologic response 12 weeks post treatment. With Vertex’s drug called Telaprevir, 74 percent of co-infected study individuals were cured, after finishing treatment. These two drugs in the past year have given hope to many, when interferon and ribavirin alone gave people with chronic HCV infection only about a 15-20 percent cure rate.

March 2012, the Institute of Medicine (IOM) Report “Monitoring HIV Care in the United States” Indicators and Data SystemsThe Office of National AIDS Policy (ONAP) asked the IOM to convene an expert committee to identify core indicators related to continuous HIV clinical care and access to supportive services, and to monitor the effect of both the National HIV/AIDS Strategy (NHAS) and ACA on improving HIV care. The committee outlined a number of obstacles that prevent people living with HIV to optimal health. These obstacles included; late diagnosis, delayed access to care, delayed prescriptions and intermittent use of life-saving antiretroviral therapy (ART), untreated substance use disorders, and unmet basic needs.

The expert committee concluded that the vision provided by the National HIV/AIDS strategy and the changes to the US Health Care system embodied in the ACA both have the potential to help curb the HIV epidemic and blunt it’s impact. The changed eligibility requirements for public and private health insurance resulting from ACA are expected to expand access to prescription medications and clinical care for HIV and other conditions that affect people living with HIV/AIDS (PLWHA), including mental health and substance use disorders.

The expert committee also concluded that an increased focus on why people diagnosed with HIV fail to enter or remain in care, as well as removing obstacles to care, such as by providing supportive services, will improve individual health and reduce transmission of HIV to others. As the committee outlined in its report it is critical to continue to monitoring improvements in HIV care resulting from the NHAS and ACA.

March 29th, 2012: The National Institutes of Health updated its guidelines

It’s biggest update is a recommendation that ALL HIV treatment Naive patients should be on Anti-Retroviral therapy. Though, they triaged their recommendations as follows:

The Panel’s recommendations are listed below.• ART is recommended for all HIV-infected individuals. The strength of this recommendationa varies on the basis of pretreatment CD4 cell count: o CD4 count <350 cells/mm3 (AI) o CD4 count 350 to 500 cells/mm3 (AII) o CD4 count >500 cells/mm3 (BIII)• Regardless of CD4 count, initiation of ART is strongly recommended for individuals with the following conditions: o Pregnancy (AI) (see perinatal guidelines for more detailed discussion) o History of an AIDS-defining illness (AI) o HIV-associated nephropathy (HIVAN) (AII) o HIV/hepatitis B virus (HBV) coinfection (AII)• Effective ART also has been shown to prevent transmission of HIV from an infected individual to a sexual partner. Therefore, ART should be offered to patients who are at risk of transmitting HIV to sexual partners (AI [heterosexuals] or AIII [other transmission risk groups]).• Patients starting ART should be willing and able to commit to treatment and should understand the benefits and risks of therapy and the importance of adherence (AIII). Patients may choose to postpone therapy, and providers, on a case-by-case basis, may elect to defer therapy on the basis of clinical and/or psychosocial factors.

• All HIV-infected patients should be screened for hepatitis C virus (HCV) infection, preferably before starting antiretroviral therapy (ART). • ART may slow the progression of liver disease by preserving or restoring immune function and reducing HIV-related immune activation and inflammation. For most HIV/HCV-coinfected patients, including those with cirrhosis, the benefits of ART outweigh concerns regarding drug-induced liver injury (DILI). Therefore, ART should be considered for HIV/HCV-coinfected patients, regardless of CD4 count (BII). • Initial ART combination regimens for most HIV/HCV-coinfected patients are the same as those for individuals without HCV infection. However, when treatment for both HIV and HCV is indicated, consideration of potential drug-drug interactions and overlapping toxicities should guide ART regimen selection or modification (see discussion in the text). • Combined treatment of HIV and HCV can be complicated by large pill burden, drug interactions, and overlapping toxicities. Although ART should be initiated for most HIV/HCV-coinfected patients regardless of CD4 cell count, in ART-naive patients with CD4 counts >500 cells/mm3 some clinicians may choose to defer ART until completion of HCV treatment. • In patients with lower CD4 counts (e.g., <200 cells/mm3), it may be preferable to initiate ART and delay HCV therapy until CD4 counts increase as a result of ART.

The RAPID 20 minute Orasure Home Test KitUp for FDA Approval, this at home test kit has been in the planning stages for years. There is already a Home Access test kit on the market in drug stores and supermarkets across the country to test for HIV and Hepatitis C; this new test from Orasure would be the standard 20 minute test you need to go to clinics for now. This test is already available in Europe could be approved within the next year here in the US. Also, it’s no surprise a rapid 20 minute at home Hepatitis C test is in development too.

Also in the next year battles will rage over PrEP (Pre-Exposure Prophylaxis), and an introduction of another Quad pill or two could be further game changers in the face of HIV/AIDS, as will be discussions surrounding a ‘common portal’ for easier access and linkage to care for people living with HIV/AIDS.

DR Colfax

Within the past couple weeks the White House has chosen D.R Colfax to head up the Office of National AIDS Policy (ONAP). This replacement of Jeff Crowley, who resigned in November 2011, is being hailed as a wise choice by many in the community. Undoubtedly D.R Colfax will alone be a game changer in the face of HIV/AIDS.

Grant Colfax, MD, Director of the HIV Prevention Section in the San Francisco Department of Public Health will coordinate the continuing efforts of the government to reduce the number of HIV infections across the United States. “Dr. Colfax has been instrumental in the decline of new HIV infections in San Francisco in recent years,” said San Francisco AIDS Foundation CEO Neil Giuliano. “His unique blend of experience serving on the front lines of the epidemic, implementing the national strategy at the local level, working as a direct service provider within the Ryan White CARE system, and conducting cutting-edge research makes him the right person at the right time to lead the Obama administration’s efforts to end HIV/AIDS in the United States.”

“Dr. Colfax will play a critical role over the next several years to ensure the implementation of the Affordable Care Act and HIV service integration to address the health care needs of people living with HIV,” said Ernest Hopkins, director of legislative affairs at San Francisco AIDS Foundation. “Having worked closely with him on complex issues and having seen his consensus-building skills among diverse populations, including communities of color, I am confident that the AIDS community will have a strong advocate within the administration. I know Dr. Colfax will work to ensure that the coming changes to our health care system are made thoughtfully, carefully, and with a strong focus on improving the health status of the most vulnerable people.” -–San Francisco AIDS Foundation.

Conclusion

The pace doesn’t seem to be slowing down with regard to advancements in science, research, new developments, and new guidelines for HIV AND Hepatitis C. It can only be surmised that in the next year, and years to come, better treatments will become available, more people will enter care, and the forever quest for the cure will become closer and closer to a reality. D.R Colfax will undoubtedly be a strong advocate inside the white house for people living with HIV/AIDS (PLWHA), with firsthand knowledge of events happening on the ground, and capabilities and the knowledge to implement ideas and sway opinions inside congress. I look forward to the continuing work of the National AIDS Strategy, and look forward to the work of D.R Colfax and the Office of National AIDS Policy. Welcome to Washington, D.C, D.R Colfax!http://riseuptohiv.blogspot.ca/2012/03/game-changers-in-hivaids-this-past-year.html

BALTIMORE–(BUSINESS WIRE)– Profectus BioSciences, Inc., a leader in the development of therapeutic and preventive vaccines against infectious diseases, announced that a phase 1 study to test the safety and immunogenicity of a recombinant vesicular stomatitis virus (rVSV)-vectored HIV vaccine initiated on October 26th and, as of December 27th, 20 volunteers have been immunized. VSV is a type of RNA virus that can infect both insects and mammals. It is commonly used in laboratory settings as a gene delivery vector without the potential for integration, a characteristic that provides a safety advantage in vaccine applications. The first studies to demonstrate the potential of rVSV as an HIV vaccine vector were performed in the laboratories of Dr. John K. Rose at Yale University more than a decade ago. The recombinant version used in this new vaccine study is able to replicate in human cells, but has been attenuated (weakened) so as not to cause illness in animals or humans.

The novel rVSV vector, expressing the HIV-1 gag protein, is being evaluated in a trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The study is being conducted by the NIAID-funded HIV Vaccine Trials Network (HVTN) under a protocol designated HVTN 090.

The phase 1, placebo-controlled, dose-escalation study will enroll 60 HIV-uninfected adults. It will assess the safety and immunogenicity of increasing doses of the rVSV HIV-1 gag vaccine administered by intramuscular injection. Assays conducted by the HVTN Central Immunology Laboratories will measure the ability of the vaccine to induce both antibody and cell-mediated immune responses to the HIV gag protein. The vaccine was found to be safe and immunogenic in non-human primates, and is the first vaccine based on an rVSV platform to be tested in humans.

Dr. John Eldridge, Chief Scientific Officer, said: “Profectus is very pleased to announce the first clinical evaluation of the rVSV HIV-1 vaccine. This replication competent delivery vector provides both unique immunogenicity and the high manufacturing yields needed for an HIV vaccine intended for worldwide use.”

About the rVSV HIV-1 gag vaccine

The rVSV HIV-1 gag vaccine consists of an attenuated replication competent form of the Indiana serotype of rVSV that expresses the HIV-1 gag protein. The vaccine was designed to elicit a robust cell mediated immune response to the HIV-1 gag protein, and will be supplied in frozen formulation to this proof-of-concept study. Ongoing studies are examining the potential to develop a lyophilized formulation that will replace the frozen form, and greatly simplify distribution of vaccine to the developing world.

About NIAID

NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov/.

About the HVTN

The HIV Vaccine Trials Network (HVTN) is an international collaboration of scientists and educators searching for an effective and safe HIV vaccine. The HVTN’s mission is to facilitate the process of testing preventive vaccines against HIV/AIDS. The HVTN conducts all phases of clinical trials, from evaluating experimental vaccines for safety and the ability to stimulate immune responses, to testing vaccine efficacy. Support for the HVTN is provided through a cooperative agreement from the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH). The Network’s HIV Vaccine Trial Units are located at leading research institutions in 27 cities on four continents. Internationally renowned HIV vaccine and prevention researchers lead the units.

About Profectus BioSciences, Inc.

Profectus BioSciences, Inc. is a technology based vaccine company devoted to the treatment and prevention of infectious disease and related cancer, with the goal of reducing morbidity and mortality. Since its inception in 2003, the Company’s strategic intent has been to acquire and develop the technologies needed to achieve this goal. The Company has licensed a group of vaccine-based technologies from Wyeth Vaccines (now Pfizer, Inc.) that greatly enhance the immunogenicity of prophylactic and therapeutic vaccines based on a “prime-boost” strategy. This strategy uses the delivery of a best-in-class pDNA vaccine to “prime” the immune system, followed by a first-in-class “boost” with an rVSV vector. Current disease and virus targets include hepatitis C virus (HCV), human papilloma virus (HPV), herpes simplex virus type 2 (HSV-2), human immunodeficiency virus (HIV), Ebola virus, Marburg Virus, and malaria. The Profectus rVSV HIV-1 vaccine program has been supported through the award of a $ 22.5M HIV Vaccine Design and Development Teams (HVDDT) contract HHSN272200800061C from the NIH that has supported the research, development, and manufacturing costs of the rVSVIN HIV-1 gag vaccine.

Pablo Tebas from the University of Pennsylvania updated conference-goers on new data from 2 open-label cohorts previously presented at CROI 2011 and ICAAC 2011. The data bolster the zinc finger nuclease concept as an HIV therapy and give a green light for moving forward in expanded trials.

Participants in these studies donate blood cells in a procedure called apheresis. CD4 cells are extracted and processed with the zinc finger nuclease to disrupt expression of the CCR5 co-receptor, which is necessary for many strains of HIV to enter cells. The altered SB-728-T cells -- made resistant to HIV -- are allowed to multiply in the laboratory and then re-infused back into the same participant.

So far, in small cohorts from Philadelphia and San Francisco, the concept has proven safe, and the modified CD4 cells were shown to engraft and persist in the body. "The cellssurvive, seem to behave normally, and go to places they are supposed to go," Tebas explained at a CROI press conference about approaches to a cure for HIV.

Tebas presented further data on participants given 1 infusion of 5 to 30 billion SB-728-T cells who have been followed up to 700 days thus far. These participants included 6 immunological responders with CD4 cell counts > 450 cells/mm3 and 15 immunological non-responders with CD4 counts < 500 cells/mm3.

All but 2 were men and the average age was approximately 47 years. The immunological responders had been HIV positive for 12 years on average and had a mean baseline CD4 count of about 920 cell/mm3. The non-responders had been positive for 18 years on average and had a mean CD4 count of about 330 cells/mm3.

One remaining question was whether HIV RNA levels would be affected by SB-728-T cells. To show this, participants stopped antiretroviral therapy with careful monitoring during the trial, known as analytic treatment interruption.

A single infusion of SB-728-T is safe and well tolerated.There have been no serious adverse events except 1 case of arthritis that resolved after a few days, most likely a reaction related to the transfusion.After about 1 year, dramatic increases in total CD4 cells were sustained in both groups.Modified cells engrafted, expanded, and persisted for more than 1 year in the blood and gut-associated lymphoid tissue.Participants' CD4:CD8 ratios normalized.Increases in IL-2, IL-7, and IL-15 were seen, thought to be associated with expansion of CD4 cells.In the immunological responder group, all participants saw an initial increase in HIV viral load and a subsequent drop during a 12-week analytic treatment interruption.1 participant who was later found to be CCR5-delta 32 heterozygous had an initial increase in viral load and then dropped to undetectable during a 12-week treatment interruption.6 patients analyzed with the sensitive PCR assay were shown to have modest increases in integrated DNA during treatment interruption, but levels returned to baseline a few weeks after resumption of antiretroviral drugs.Further research into SB-728-T zinc finger therapy is being conducted in 2 clinical trials for participants who are CCR5-delta 32 heterozygous. These people have 1 copy of an uncommon natural genetic mutation that produces T-cells lacking CCR5. As Tebas explained, "nature did half the job" for the heterozygous participant who achieved undetectable viral load during treatment interruption in the current study.

In addition, a chemotherapeutic conditioning agent will be used in 1 infusion prior to the SB-728-T infusion to make way for more modified cells.

Various approaches to curing HIV will "probably have to be used in combination," Tebas suggested. "This might be one of the strategies we will use the future."

ScienceDaily (Apr. 12, 2012) — Expanding on previous research providing proof-of-principal that human stem cells can be genetically engineered into HIV-fighting cells, a team of UCLA researchers have now demonstrated that these cells can actually attack HIV-infected cells in a living organism.See Also:Health & MedicineHIV and AIDSStem CellsImmune SystemPlants & AnimalsBiotechnologyMiceBiologyReferenceT cellNatural killer cellEmbryonic stem cellSomatic cellThe study, published April 12 in the journal PLoS Pathogens, demonstrates for the first time that engineering stem cells to form immune cells that target HIV is effective in suppressing the virus in living tissues in an animal model, said lead investigator Scott G. Kitchen, an assistant professor of medicine in the division of hematology and oncology at the David Geffen School of Medicine at UCLA and a member of the UCLA AIDS Institute."We believe that this study lays the groundwork for the potential use of this type of an approach in combating HIV infection in infected individuals, in hopes of eradicating the virus from the body," he said.In the previous research, the scientists took CD8 cytotoxic T lymphocytes -- the "killer" T cells that help fight infection -- from an HIV-infected individual and identified the molecule known as the T cell receptor, which guides the T cell in recognizing and killing HIV-infected cells. However, these T cells, while able to destroy HIV-infected cells, do not exist in great enough quantities to clear the virus from the body. So the researchers cloned the receptor and used this to genetically engineer human blood stem cells. They then placed the engineered stem cells into human thymus tissue that had been implanted in mice, allowing them to study the reaction in a living organism.The engineered stem cells developed into a large population of mature, multi-functional HIV-specific CD8 cells that could specifically target cells containing HIV proteins. The researchers also discovered that HIV-specific T cell receptors have to be matched to an individual in much the same way an organ is matched to a transplant patient.In this current study, the researchers similarly engineered human blood stem cells and found that they can form mature T cells that can attack HIV in tissues where the virus resides and replicates. They did so by using a surrogate model, the humanized mouse, in which HIV infection closely resembles the disease and its progression in humans.In a series of tests on the mice's peripheral blood, plasma and organs conducted two weeks and six weeks after introducing the engineered cells, the researchers found that the number of CD4 "helper" T cells -- which become depleted as a result of HIV infection -- increased, while levels of HIV in the blood decreased. CD4 cells are white blood cells that are an important component of the immune system, helping to fight off infections. These results indicated that the engineered cells were capable of developing and migrating to the organs to fight infection there.The researchers did note a potential weakness with the study: Human immune cells reconstituted at a lower level in the humanized mice than they would in humans, and as a result, the mice's immune systems were mostly, though not completely, reconstructed. Because of this, HIV may be slower to mutate in the mice than in human hosts. So the use of multiple, engineered T cell receptors may be one way to adjust for the higher potential for HIV mutation in humans."We believe that this is the first step in developing a more aggressive approach in correcting the defects in the human T cell responses that allow HIV to persist in infected people," Kitchen said.The researchers will now begin making T cell receptors that target different parts of HIV and that could be used in more genetically matched individuals, he said.http://

Screening for a new clinical study, called RV305, recently began at the Bang Lamung Hospital in the Chonburi Province of Thailand. This small immunogenicity study will evaluate extended boosting regimens using the same vaccine components that were used in RV144. The goal of the secondary boost is to try to extend and increase the immune response seen in RV144.

This is the first of two planned clinical trials that will evaluate extended boosting regimens using the same vaccine components that were used in RV144. The next study, RV306, should begin later in 2012.

RV144 results suggest that the protection against HIV appeared highest at 6-12 months, based on post-hoc analysis (60%, 95% CI 22, 80). Researchers seek to sustain or increase this effect, and these clinical trials will enable them to collect more data and samples for immunogenicity studies.

RV305 will test three late-boost regimens in RV144 trial participants who received the full vaccination schedule at either of two sites in Chon Buri Province, Thailand. At weeks zero and 24 either placebo or active vaccine will be administered to participants. Group one will receive both vaccine products used in the RV144 trial—ALVAC and AIDSVAX. Group two will receive only AIDSVAX and group three will receive only ALVAC. The outcome of this trial will help determine the most appropriate vaccination schedule for a future planned efficacy trial.